(23 days)
Not Found
No
The device description and performance studies focus on the chemical composition and stability of a quality control product for an immunoassay, with no mention of AI or ML technologies.
No.
This device is a quality control product used to verify the performance of an immunoassay analyzer, not to treat a medical condition.
No.
This device is a quality control product used to ensure the accuracy of an immunoassay, not to diagnose a disease or condition in a patient.
No
The device is a lyophilized product consisting of human TSH in an equine serum matrix, which is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is used for "quality control of the Elecsys TSH immunoassay on the Elecsys and cobas e immunoassay analyzers." Immunoassays are laboratory tests performed on biological samples (in vitro) to measure the presence or concentration of a substance. Quality control materials are essential components of IVD testing to ensure the accuracy and reliability of the results.
- Device Description: The description details the composition of the product, which is a lyophilized material containing human TSH in a matrix. This material is designed to be used in a laboratory setting with specific analyzers.
- Mentions of Human Material and Testing: The description mentions the use of human material and testing for infectious agents, which is a common practice for IVD products that may come into contact with biological samples or are derived from human sources.
- Reference to European Directive 98/79/EC: This directive is the European Union's directive on in vitro diagnostic medical devices. Compliance with this directive is a strong indicator that the device is considered an IVD.
- Performance Studies: The summary of performance studies describes evaluations related to value assignment, stability, and reconstitution time, which are typical studies performed for IVD quality control materials to demonstrate their suitability for use in diagnostic testing.
- Key Metrics: The key metrics listed (Precision, % CV, Acceptance range of Assigned Value, % Recovery) are standard performance indicators for IVD quality control materials.
- Predicate Device: The identification of a predicate device (Elecsys PreciControl TSH) with a K number (K962573) indicates that this device is being compared to a previously cleared IVD device.
All of these points strongly support the classification of Elecsys PreciControl TS as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Elecsys PreciControl TS is used for quality control of the Elecsys TSH immunoassay on the Elecsys and cobas e immunoassay analyzers.
Product codes
JJX
Device Description
The Elecsys PreciControl TS is a lyophilized product consisting of human TSH at a euthyroid level in an equine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Elecsys PreciControl TS was evaluated for value assignment, stability, and reconstitution.
Value Assignment:
Procedure for Value Assignment: The PreciControl TS is assigned an analyte-specific value with the Elecsys TSH immunoassay. The Elecsys TSH assay was standardized against the 2nd IRP WHO Reference Standard 80/558. Values are assigned for each lot of PreciControl TS in combination with each assay reagent lot available. The controls are run in duplicate on at least three (3) MODULAR ANALYTICS E170 measuring cells. The assigned value of each control level is defined as the median value obtained over at least six (6) determinations of the respective control level.
Acceptance Criteria:
a. Precision of the control determinations: 9% CV for TSH at 0.2 µIU/mL.
b. Percent difference between assigned and target (nominal) values: 60-140% acceptance range of Assigned Value for TSH at 0.2 µIU/mL.
c. Analyzer-to-analyzer variability: 90-110% for Assigned value on Additional vs. Master Platform.
Conclusion: Acceptance criteria for all stages of the process were met, supporting the target values and ranges.
Stability Studies:
Three studies were performed to verify stability claims. All studies were performed on the cobas e 411 analyzer.
Study 1 and 2. Stability after Reconstitution:
Study 1: On-test material was reconstituted and stored for 73 h at +2℃ to +8℃ and +20°C to 25°C for 6h. Reference material was lyophilized and stored at +2℃ to +8℃. Tested in duplicate. Acceptance criterion: 90-110% recovery of the reference material value. Result: 96.6% recovery.
Study 2: On-test material was reconstituted and stored for 32 days at -20°C and +20°C to 25°C for 6h. Reference material was lyophilized and stored at +2℃ to +8℃. Tested in duplicate. Acceptance criterion: 90-110% recovery of the reference material value. Result: 101.7% recovery.
Conclusion: Data support the package insert claim that reconstituted PreciControl TS is stable for up to 31 days at -20°C, 72 hours at 2-8°C, and 5 h at 20-25°C on the analyzers.
Study 3. Real-Time Stability:
The PreciControl TS test material is stored at +2 to +8°C and tested at specified intervals over the shelf life. Data for 6, 9, 12, 16, 19, 25, and 37 months tested in duplicate. Acceptance criterion: 90-110% recovery compared to the unstressed reference value (stored at -20°C). Current shelf life claim is 24 months, based on real-time data from three lots. Testing will continue to support a 36-month claim.
Results:
Lot DR01: TSH % recovery: 106 (6m), 100 (9m), 103 (12m), 99 (16m), 103 (19m), 102 (25m).
Lot DR02: TSH % recovery: 99 (6m), 100 (9m), 103 (12m), 98 (16m), 102 (19m), 102 (25m).
Lot DR03: TSH % recovery: 100 (6m), 99 (9m), 95 (12m), 99 (16m), 101 (19m), 99 (25m).
Conclusion: Data support the current package insert claim of shelf life of 24 months.
Reconstitution Time Study:
PreciControl TS was reconstituted for 30 minutes (reference) and 60 minutes. Samples evaluated in duplicate on the cobas e 411 analyzer. Acceptance criterion: 90-110% recovery compared to the 30-minute reconstituted material.
Result: 100.0% recovery (0.174 µIU/mL for both).
Conclusion: Data support the package insert claim that the PreciControl TS is completely reconstituted after 30 minutes.
Overall Conclusion: The data demonstrate that the performance of the Elecsys PreciControl TS is substantially equivalent to that of the predicate device, Elecsys® PreciControl TSH.
Key Metrics
Recovery for stability studies (90-110% acceptance criterion, results 96.6%, 101.7%, and various within range for real-time stability)
% CV for precision (9% for TSH)
% difference between assigned and target values (60-140% acceptance range)
Analyzer-to-analyzer variability (90-110% acceptance range)
Predicate Device(s)
Elecsys PreciControl TSH (K962573)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
MAR 2 7 2014
510(k) Summary
.
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
Name,
Address,
Contact | Roche Diagnostics
9115 Hague Road, P.O. Box 50416
Indianapolis, IN 46250-0416
Contact Person: Jane Phillips
Phone: 317-521-3338
Fax: 317-521-2324
Email: jane.phillips@roche.com |
| | Date Prepared: March 12, 2014 |
1
| Device Name | Proprietary name: | Elecsys PreciControl TS |
|---|---|---|
| Common name: | Elecsys PreciControl TS | |
| Classification name: | Quality control material (assayed and unassayed) | |
| Establishment | ||
| Registration | For the Elecsys PreciControl TS, the establishment registration number | |
| (Roche Diagnostics GmbH Mannheim) is 9610126. The establishment | ||
| registration number for Roche Diagnostics United States is 1823260. |
Classification The FDA has classified the product as a Class I Reserved device.
| Panel | Product
Code | Classification Name | Regulation
Citation |
|--------------------|-----------------|-----------------------------------------------------|------------------------|
| Clinical Chemistry | JJX | Quality control material
(assayed and unassayed) | 862.1660 |
| Predicate
Device | The Elecsys PreciControl TS is substantially equivalent to other products in
commercial distribution intended for similar use. We claim equivalency to
the currently marketed Elecsys PreciControl TSH (K962573). |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | The Elecsys PreciControl TS is a lyophilized product consisting of human
TSH at a euthyroid level in an equine serum matrix. During manufacture, the
analyte is spiked into the matrix at the desired concentration levels. All
human material should be considered potentially infectious. All products
derived from human blood are prepared exclusively from the blood of donors
tested individually and shown to be free from HBsAg and antibodies to HCV
and HIV. The testing methods applied were FDA-approved or cleared in
compliance with the European Directive 98/79/EC, Annex II, List A. |
| Intended Use | Elecsys PreciControl TS is used for quality control of the Elecsys TSH
immunoassay on the Elecsys and cobas e immunoassay analyzers. |
| Substantial
Equivalence | The Elecsys PreciControl TS is equivalent to the Elecsys PreciControl TSH
(K962573). |
| | Continued on next page |
2
Table 1 below compares Elecsys PreciControl TS with the predicate device, Comparison PreciControl TSH. Table
| Table 1. Comparison of Candidate and Predicate Device | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | ------------------------------------------------------- |
. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
.
| Characteristic | Elecsys PreciControl TS
(Candidate Device) | Elecsys® PreciControl TSH (K962573) |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Elecsys PreciControl TS is used for
quality control of the Elecsys TSH
immunoassay on the Elecsys and
cobas e immunoassay analyzers. | PreciControl TSH is used for quality
control of the Elecsys TSH
immunoassay on the Elecsys and
cobas e immunoassay analyzers. |
| Format | Lyophilized material needs to be
reconstituted with 2.0 mL of distilled
or deionized water. | Liquid (2.0 mL) |
| Analyte | Recombinant human TSH | Same |
| Matrix | Equine serum | Same |
| Levels | One | Same |
| Target
Ranges | TSH: ~0.2 $ μIU/mL $ | Same |
| Stability | Lyophilized:
• Up until labeled expiration date at
2-8°C
Reconstituted:
• -20°C: 31 days (1 month) (freeze
only once)
• 2-8° C: 72 hours (3 days)
• on the analyzers (20-25°C): up to 5
hours | Unopened:
• Store at 2-8°C until expiration date
Opened:
• Unopened at 2-8°C: Up to the stated
expiration date
• Opened at 2-8°C: 12 weeks
• on the analyzers (20-25°C): up to 5
hours |
Continued on next page
3
| Characteristic | Elecsys PreciControl TS
(Candidate Device) | Elecsys PreciControl TSH (K962573) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Handling | Carefully dissolve the contents of
one bottle by adding exactly 2.0 mL
of distilled or deionized water and
allow to stand closed for 30 minutes
to reconstitute. Mix carefully,
avoiding foam formation.
Transfer aliquots (500µl) of the
reconstituted control into empty
labeled snap-cap bottles (ControlSet
Vials)
Attach the supplied labels to the
additional bottles. Store the aliquots
immediately at -20°C.
Discard of aliquot after performing
the control procedure since they
should be used only once. | The control is supplied ready-for-use
in bottle compatible with the system.
The control should only be left on the
analyzer during performance of
quality control. After use, close the
bottle as soon as possible and store at
2-8°C. Because of possible
evaporation effects, not more than 20
quality control procedures per bottle
should be performed. |
| Traceability | The Elecsys TSH assay was
standardized against the 2nd IRP
WHO Reference Standard 80/558 | Same |
Table 1. Comparison of Candidate and Predicate Devices, continued
The Elecsys PreciControl TS was evaluated for value assignment, stability, and reconstitution. Characteristics
and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of
・・・・・・・・・・・・・・・・・・・・・
The data demonstrate that the performance of the Elecsys PreciControl TS is Conclusion substantially equivalent to that of the predicate device, Elecsys® PreciControl TSH.
Performance
. . . . . . . .
4
Value Assignment
1. Standardization and traceability
Procedure for Value Assignment
The PreciControl TS is assigned an analyte-specific value with the Elecsys TSH immunoassay. The Elecsys TSH assay was standardized against the 2nd IRP WHO Reference Standard 80/558.
2. Value Assignment
Values are assigned for each lot of PreciControl TS in combination with each assay reagent lot available. The controls are run in duplicate on at least three (3) MODULAR ANALYTICS E170 measuring cells. The assigned value of each control level is defined as the median value obtained over at least six (6) determinations of the respective control level.
Acceptance Criteria for Value assignment, specified in Table 2.
- a. Precision of the control determinations
- b. Percent difference between assigned and target (nominal) values
- c. Analyzer-to-analyzer variability
For additional analyzer platforms, the same value assignment procedure is performed. The assigned values obtained on the additional analyzers are compared to those obtained on the MODULAR ANALYTICS E170 (the master analyzer).
Table 2. Value Assignment Acceptance Criteria for PreciControl TS
| | Target
Value
[µIU/mL] | (a)
Precision,
% CV | (b)
Acceptance range
of Assigned
Value,
[%] | (c)
Assigned value
on Additional
vs. Master
Platform,
% |
|-----|-----------------------------|---------------------------|---------------------------------------------------------|------------------------------------------------------------------------|
| TSH | 0.2 | 9 | 60-140 | 90-110 |
Conclusion: Acceptance criteria for all stages of the process were met, supporting the target values and ranges above.
5
Stability Studies
Stability
Studies
Three studies were performed in order to verify the stability claims for the PreciControl TS.
All stability studies were performed on the cobas e 411 analyzer.
Study 1 and 2. Stability after Reconstitution:
Study 1
The on-test and reference materials were tested in duplicate. The on-test material was reconstituted and stored for 73 h at +2℃ to +8℃ and afterwards stored in snap-cap bottles for 6h at +20°C to 25°C. The reference material was lyophilized material stored at +2℃ to +8℃. The on-test recovery was calculated as a percent of the reference value.
The PreciControl TS lot was evaluated in duplicate on the cobas e 411. The acceptance criterion was 90-110% recovery of the reference material value.
| Table 3. Stability of Reconstituted Lyophilized PreciControl TS | ||
|---|---|---|
| ----------------------------------------------------------------- | -- | -- |
| Stability of reconstituted PreciControl TS on cobas e 411 | |||
|---|---|---|---|
| Sample | Reference | ||
| [µIU/mL] | Stressed control | ||
| [µIU/mL] | % Recovery | ||
| PC TS | 0.174 | 0.168 | 96.6 |
Continued on next page
6
Stability Studies
Stability Study 2 Studies The on-test and reference materials were tested in duplicate. The on-test material was reconstituted and stored for 32 days at -20°C and afterwards stored in snap-cap bottles for 6h at +20°C to 25°C. The reference material was lyophilized material stored at +2℃ to +8℃. The on-test recovery was calculated as a percent of the reference value.
The PreciControl TS lot was evaluated in duplicate on the cobas e 411. The acceptance criterion was 90-110% recovery of the reference material value.
| Stability of reconstituted Lyophilized on cobas e 411 | |||
|---|---|---|---|
| Sample | Reference | ||
| [µIU/mL] | Stressed control | ||
| [µIU/mL] | % Recovery | ||
| PC TS | 0.174 | 0.177 | 101.7 |
Table 4. Stability of Reconstituted Lyophilized PreciControl TS
Conclusion: The data support the package insert claim that reconstituted PreciControl TS is stable for up to:
31 days at -20°C 72 hours at 2-8°C 5 h at 20-25°C on the analyzers
Continued on next page
7
Stability Studies
| Stability | Study 3. Real-Time Stability: | |
|---|---|---|
| Studies | ||
| continued | The real-time stability is being evaluated as follows: | |
| In the on-going real-time stability study, the PreciControl TS test material is | ||
| stored at +2 to +8°C. The controls are tested at specified intervals over the | ||
| shelf life of the device up to the planned shelf life plus one month. | ||
| Data for the time-points at 6, 12, 16, 19, 25 and 37 months tested in duplicate | ||
| will be available. The average on-test recovery value is calculated as percent | ||
| recovery compared to the unstressed reference value (stored at -20°C). | ||
| The acceptance criterion is a recovery of 90-110% of the unstressed | ||
| reference. | ||
| Currently, the shelf life claim is 24 months. This is based on real-time | ||
| stability data of three lots. | ||
| The testing will be continued with this stability protocol until data is available | ||
| to support a claim of 36 months. | ||
| A |
Conclusion: Data support the current package insert claim of shelf life of 24 months.
| Lot | Level | On-Test as a Percent of Reference, % | ||||||
|---|---|---|---|---|---|---|---|---|
| 6 | 9 | 12 | 16 | 19 | 25 | 37 | ||
| DR01 | TSH | 106 | 100 | 103 | 99 | 103 | 102 | |
| DR02 | TSH | 99 | 100 | 103 | 98 | 102 | 102 | |
| DR03 | TSH | 100 | 99 | 95 | 99 | 101 | 99 |
・・・・・
:
Career States
Table 5. Real-time Stability testing plan for PreciControl TS
Continued on next page
.
8
Reconstitution
PreciControl TS was reconstituted for 30 minutes (reference) and 60 Reconstitution minutes. Samples were evaluated in duplicate on the cobas e 411 analyzer. Time Study The average recovery after 60 minutes of reconstitution will be calculated as percent recovery compared to the value obtained at 30 minutes of reconstitution (the reference value).
The acceptance criterion is recovery of 90-110% of the value obtained for the 30 minute reconstituted material.
| Reference result
(30 min reconstitution)
TS [µIU/mL] | On-Test result
(60 min
reconstitution)
TS [µIU/mL] | % Recovery |
|------------------------------------------------------------|-------------------------------------------------------------|------------|
| 0.174 | 0.174 | 100.0 |
Conclusion: The data support the package insert claim that the PreciControl TS is completely reconstituted after 30 minutes.
9
Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2014
ROCHE DIAGNOSTICS JANE PHILLIPS REGULATORY PROGRAM MANAGER 9115 HAGUE ROAD INDIANAPOLIS IN 46250
Re: K140534
Trade/Device Name: Elecsys PreciControl TS Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJX Dated: February 27, 2014 Received: March 4, 2014
Dear Ms. Phillips:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
10
Page 2-Ms. Phillips
If you desire specific advice for your device on our labeling regulations (2) CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetw/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
11
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140534
Device Name Elecsys PreciControl TS
Indications for Use (Describe)
Elecsys PreciControl TS is used for quality control of the Elecsys TSH immunoassay on the Elecsys and cobas e immunoassay analyzers.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Yung W. Chan -S
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."